Primary fungal profilaxis with Liposomal Amphotericin B at the dose of 10 mg/kg a week in adult patient undergoing orthotopic liver transplantation and high risk for postoperative fungal infection: a prospective study - ND
- Conditions
- Postoperative fungal infection.MedDRA version: 6.1Level: PTClassification code 10052366
- Registration Number
- EUCTR2007-001924-11-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
adult patient undergoing orthotopic liver transplantation and high risk for postoperative fungal infection
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
renal function failure due to AmBL
renal function failure of other causes
Woman pregnant or breast feedinf
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate the safety of liposomal amphotericin B at the dose of 10 mg/Kg a week for 3-4 weeks;Secondary Objective: The second end point is to evaluate the efficacy of this dose (10 mg/Kg a week) to prevent fungal infections in patients at high risk, meaning with one or two of the supra-mentioned conditions. <br><br>A further end-point will be the compliance of patients and operators with this dosage.;Primary end point(s): safety of liposomal amphotericin B at the dose of 10 mg/Kg a week for 3-4 weeks
- Secondary Outcome Measures
Name Time Method